Optical Coherence Tomography (OCT) Imaging of Post Coil Aneurysm Healing.

This study has been completed.
Sponsor:
Collaborators:
Beckman Laser Institute University of California Irvine
University of California, Irvine
Information provided by (Responsible Party):
Montana Compton, University of California, Irvine
ClinicalTrials.gov Identifier:
NCT00556309
First received: November 7, 2007
Last updated: December 27, 2012
Last verified: December 2012
  Purpose

At Beckman Laser Institute, University of California, Irvine, we have developed diagnostic device call 'Optical Coherence tomography (OCT).'

OCT is an imaging technique capable of performing high-resolution,cross-sectional imaging. OCT enables real-time, in situ visualization of tissue microstructure without the need to excise and process the specimen as required for conventional biopsy and histopathology.

OCT is analogous to ultrasound except that imaging is performed with light instead of acoustic waves. OCT measures light reflected from turbid structures. Consequently, OCT is a powerful method to image biological tissue in-vivo at high resolution.

The objective of the study is to demonstrate a healing response in coiled aneurysms using OCT imaging at three months. The healing process constitutes fibrosis, and organization of the coiled aneurysm as well as re-endothelization.


Condition Intervention
Aneurysm
Device: OCT

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Optical Coherence Tomography (OCT) Imaging of Post Coil Aneurysm Healing.

Resource links provided by NLM:


Further study details as provided by University of California, Irvine:

Primary Outcome Measures:
  • Optical Coherence Tomography (OCT) Imaging of Post Coil Aneurysm Healing. [ Time Frame: up to 12 months ] [ Designated as safety issue: No ]

Enrollment: 3
Study Start Date: January 2007
Study Completion Date: May 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: OCT
    OCT image during angiogram procedure
Detailed Description:

Subjects presenting with subarachnoid hemorrhage secondary to ruptured cerebral aneurysms as well as subjects with unruptured aneurysms that are being treated using endovascular coiling will be included in the study.

An image will be acquired by the Optical Coherence Tomography (OCT) at the time of initial angiography in subjects with unruptured aneurysms, and at the three month follow up catheter angiogram for all subjects. Patients with acutely ruptured aneurysms will not be investigated with OCT at the initial intervention. Images obtained at three month follow up will be analyzed for aneurysm healing based on the presence of a membranous covering or endothelization.

Endovascular therapeutic coiling is a widely used procedure in the management of aneurysms, which is an angiogram . Following therapeutic coiling of the aneurysm the 6F endocatheter and the microcatheter used for the coiling procedure will be left in place in the internal carotid artery and parent artery lumen respectively. The OCT fiber will be inserted through the lumen of the tube on which the images will be obtained.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Primary care clinic

Criteria

Inclusion Criteria:

  • Age ≥ 18 years of age
  • Subject diagnosis of aneurysm and undergoing endovascular coiling

Exclusion Criteria:

  • Pregnant women
  • Age ≤ 18 years of age
  • Patient presenting emergently with acutely ruptured aneurysms
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00556309

Locations
United States, California
Neurosurgery department, University of California,Irvine
Irvine, California, United States, 92612
Beckman Laser Institute,University of California, Irvine
Irvine, California, United States, 92612
Sponsors and Collaborators
Montana Compton
Beckman Laser Institute University of California Irvine
University of California, Irvine
Investigators
Principal Investigator: Marlon Mathew, MD UCIMC
  More Information

No publications provided

Responsible Party: Montana Compton, Administrative Nurse Research Coordinator Beckman Laser Institute, University of California, Irvine
ClinicalTrials.gov Identifier: NCT00556309     History of Changes
Other Study ID Numbers: NIH-OCT EB-093-07
Study First Received: November 7, 2007
Last Updated: December 27, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Aneurysm
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on July 22, 2014